Federal avian flu response kicks into gear

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Apr 26, 2024 View in browser   By David Lim Driving The Day Bird flu has been found in at least 33 dairy herds across eight states, and viral fragments have been found in some commercial milk. | Nati Harnik/AP BIRD FLU UPDATE — Federal agriculture and health officials have increased communication with the public in recent days about an outbreak of avian influenza in cows across multiple states. But public health experts want the government to be more transparent about its efforts to expand testing and research. The FDA said Thursday that about 1 in 5 retail milk samples tested positive for viral fragments, suggesting the virus might have spread beyond symptomatic dairy herds. And the pathogen has been found in at least 33 dairy herds across eight states since first being detected among Texas cattle in late March, and virologists say it could be much more widespread than that data suggests. To date, however, just one person has been confirmed to have contracted the virus — a dairy worker in Texas who developed a case of conjunctivitis, or pinkeye. Federal officials and industry executives maintain the discovery of inactive fragments of the virus strain, known as H5N1, in milk sold to consumers is not worrisome in itself — instead, it’s evidence that the pasteurization process is working to neutralize the virus. What is the Biden administration telling consumers about drinking milk? The USDA, the Food and Drug Administration and the Centers for Disease Control and Prevention issued a statement Tuesday reiterating that “the commercial milk supply is safe.” That said, they did acknowledge that “the process is not expected to remove the presence of viral particles” and added that some milk samples the government has tested have contained the inactivated virus fragments. Government officials have been pretty clear that drinking raw — or unpasteurized — milk is a bad idea. Are there any other safety caveats? Yes. The administration has been careful to say that pasteurization is “likely” to inactivate the avian flu virus in milk, but they also acknowledge that the detection of the virus in dairy cows “is a novel and evolving situation” and “no studies on the effects of pasteurization on HPAI viruses (such as H5N1) in bovine milk have previously been completed.” Jennifer Nuzzo, director of the Pandemic Center at the Brown University School of Public Health, questioned why the FDA did not immediately say it would test milk products and expeditiously culture any potential virus fragments found. “Just from a government credibility standpoint, being transparent about what you’re doing, it’s important,” Nuzzo said. In an April 24 letter to Agriculture Secretary Tom Vilsack, Sen. Tammy Baldwin (D-Wis.) urged the USDA to “quickly deploy additional resources in states that have the opportunity to prevent the disease from entering herds within their borders by working directly with farmers on improving their biosecurity options.” The World Health Organization has also noted that while the risk from the avian flu outbreak to the general public is “low,” there is a “low-to-moderate” risk of infection for farmworkers and others regularly exposed to dairy cows. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Are you Kimberlee Trzeciak, FDA deputy commissioner for policy, legislation and international affairs? We want to hear from you. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).   THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists. Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY.     Eye on the FDA New leadership is coming to the Office of Executive Programs, which is part of the FDA's Center for Drug Evaluation and Research. | Manuel Balce Ceneta/AP CDER SHUFFLE — Mary Beth Clarke, a longtime FDA staffer who first joined the agency’s drug center in 2010 as a senior adviser to Dr. Janet Woodcock, will retire on June 1. The news, shared by Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research, in a staff email, means that Carter Beach will take over Clarke’s current role as director of the center’s Office of Executive Programs when she retires. Beach served as deputy director of OEP for five years. “Mary Beth was instrumental in guiding the launch of the Generic Drug User Fee Amendments, which has reshaped our generics program,” Cavazzoni wrote. “She also co-led the subsequent rounds of negotiations, and her patience and persistence helped achieve an agreement with industry that dramatically increased funding for the program.” CLOZAPINE ADCOMM — The FDA said Thursday it is planning to hold an in-person advisory committee meeting in the fall to discuss the drug safety program for Clozapine, an antipsychotic medication for schizophrenia. “At this time, the Clozapine REMS and the agency’s exercising of enforcement discretion to prevent interruption of treatment for patients has not changed,” the FDA said. “FDA takes problems with patient access to clozapine seriously, and continuity of care, patient access to clozapine, and patient safety are our highest priorities.” Coronavirus NIH: RESEARCH ACCESS FOR LONG COVID DATA — The NIH said Thursday that researchers can now request certain long Covid data from its Researching COVID to Enhance Recovery (RECOVER) Initiative. “These data include information from more than 92,000 study visits collected between Oct. 29, 2021-Sept. 15, 2023 at 79 locations throughout the United States,” the NIH said. “New RECOVER data, including data from other studies, will be added ... at regular intervals.” PCR TESTS MORE SENSITIVE — A CDC study published Thursday confirmed that reverse transcription–polymerase chain reaction testing is more accurate than rapid tests for Covid-19. “During November 2022–May 2023, among persons infected with SARS-CoV-2, sensitivity of rapid antigen tests was 47% compared with RT-PCR and 80% compared with viral culture,” the study said. “Antigen tests continue to detect potentially transmissible infection but miss many infections identified by positive RT-PCR test results.” In Congress CMMI UNDER FIRE — Top House Republicans want the Government Accountability Office to scrutinize the Center for Medicare and Medicaid Innovation — an agency tasked with lowering Medicare costs, POLITICO’s Ben Leonard reports. The issue, Budget Committee Chair Jodey Arrington (R-Texas) and Rep. Michael Burgess (R-Texas), is a Congressional Budget Office finding that models put out by CMMI instead increased spending. WHAT WE'RE READING Colombia issued a compulsory license for ViiV Healthcare HIV treatment dolutegravir, STAT’s Ed Silverman reports. A veterinary epidemiologist at Ohio State University conducted a survey of 150 milk products from the Midwest and found 58 samples had viral RNA — a finding that suggests avian flu infections among cows are wider than detected, STAT’s Megan Molteni reports.   POLITICO IS BACK AT THE 2024 MILKEN GLOBAL CONFERENCE: POLITICO will again be your eyes and ears at the 27th Annual Milken Institute Global Conference in Los Angeles from May 5-8 with exclusive, daily, reporting in our Global Playbook newsletter. Suzanne Lynch will be on the ground covering the biggest moments, behind-the-scenes buzz and on-stage insights from global leaders in health, finance, tech, philanthropy and beyond. Get a front-row seat to where the most interesting minds and top global leaders confront the world’s most pressing and complex challenges — subscribe today.     Document Drawer The FDA is soliciting feedback on what policies its Office of Clinical Pharmacology should work on developing to help grow effective drug development programs. Biogen disclosed on Wednesday it entered into an agreement to sell a rare pediatric disease priority review voucher for $103 million. Senate HELP Committee Chair Bernie Sanders (I-Vt.) wants the pharmaceutical industry to reconsider its opposition to certain proposed measures in the World Health Organization’s Pandemic Accord that he argues would help make tests, treatments and vaccines available on a more equitable basis.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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